Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND IBUPROFEN
HYDROCODONE BITARTRATE; IBUPROFEN
At a glance
Dec 31, 2003
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; IBUPROFEN
Strength
7.5MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 076604
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCODONE BITARTRATE; IBUPROFEN
- 1997VICOPROFENBrand (NDA)
NDA 020716 · ABBVIE
- 2016HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 204575 · AUROLIFE PHARMA LLC
- 2013HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 091633 · SUN PHARM INDS INC
- 2010HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 077454 · ANI PHARMS
- 2006HYDROCODONEGeneric (ANDA)
ANDA 077723 · STRIDES PHARMA
- 2004HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 076642 · AMNEAL PHARMS NY
- 2003HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 076023 · TEVA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
